Senior Clinical Data Manager/Programmer

TN United Kingdom; United Kingdom; On-site; GBP 50,000 - 90,000; Full time

Job summary

An established industry player in Life Sciences is seeking a Senior Clinical Data Manager/Programmer to lead data management projects. This pivotal role involves overseeing the completion of clinical studies, ensuring compliance with CDISC standards, and mentoring junior team members. With a focus on innovative solutions in Oncology and Rare Diseases, this position offers a unique opportunity to impact patient outcomes positively. If you have a strong background in SAS programming and a passion for advancing clinical research, this could be the perfect role for you.

Qualifications

• Minimum 4 years of experience in Clinical Data Management.
• Strong knowledge of CDISC SDTM and SAS programming.

Responsibilities

• Manage data-related tasks for clinical studies ensuring timely completion.
• Create and validate SDTM deliverables and communicate with study teams.

Skills

SAS Programming

SDTM Standards

SQL

Access Databases

Project Management

Communication Skills

Education

University degree in Medical Documentation

Life Sciences

Biological Sciences

Informatics

Job description

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Senior Clinical Data Manager/Programmer, United Kingdom

Client: Oracle

Location: United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 4df8264b1300

Job Views: 7

Posted: 26.04.2025

Expiry Date: 10.06.2025

Job Description:

Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre- and post-drug launch activities. With more than 20 years’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements – empowering the Life Sciences industry to help improve patient outcomes.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences. Oracle Life Sciences is immersed in these areas, making it an excellent opportunity to join us and make a difference to our clients and patients.

This role involves managing data-related tasks for designated studies, ensuring their completion on time and within budget. The candidate must have experience with SAS programming and strong SDTM standard knowledge. Responsibilities include creating and reviewing SDTM deliverables (annotated CRF, SDTM specifications, SDTM datasets), and communicating with study team members and sponsors regarding CDISC requirements and issues.

The individual will also guide, coach, and develop junior team members and act as a role model.

Key Responsibilities:

• Plan and execute multiple Data Management projects simultaneously.
• Create and maintain Data Management documentation such as DMP, DVP, and eCRF Completion Guidelines.
• Program and validate sponsor-specific SAS Datasets according to SDTM structure.
• Create and validate SDTM specifications and annotated CRFs.
• Generate SAS annotations and specifications based on client and CDISC standards.
• Support programming and validation of EDC databases.
• Program and validate internal and external status reports and listings.
• Create and maintain programming documentation.
• Develop programming specifications.
• Plan programming tasks to support Data Management across multiple projects.
• Resolve issues and problems throughout the project lifecycle.
• Attend sponsor meetings as required.

Desired Experience:

• University degree in Medical Documentation, Life Sciences, Biological Sciences, Informatics, or related discipline.
• At least 4 years of experience in Clinical Data Management within a pharmaceutical company or CRO.
• Programming skills in SAS, SQL, and Access databases.
• Knowledge and experience in CDISC SDTM.
• Performance-oriented with well-structured and efficient work methods.
• Ability to work independently and within interdisciplinary teams.
• Excellent planning, organizational, and communication skills.